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| United States Patent Application |
20090282004
|
| Kind Code
|
A1
|
|
Williams; Christopher P.
|
November 12, 2009
|
METHOD FOR ANALYZING, LABELING AND CERTIFYING LOW RADIOCARBON FOOD
PRODUCTS
Abstract
Methods, particularly computer-implemented methods, are provided for
analyzing, labeling, reporting, and certifying the radiocarbon abundance
levels of low radiocarbon food products, including relevant chemical
components of final products as well as components of lots used in
manufacturing, so that manufacturers, consumers or other users of these
products can have high confidence in their stated radiocarbon content and
a better understanding of their potential effectiveness in reducing
genetic damage. Other embodiments employ an algorithm to calculate an
overall value or grade or range indicative of the product's known or
estimated ability to either reduce the radiocarbon level of, or to reduce
genetic damage occurring in, newly formed chromosomal material in
consumers of such products, the chromosomal material comprising DNA and
histone proteins and remote access by consumers to the
computer-implemented methods, for example, via the Internet.
| Inventors: |
Williams; Christopher P.; (Brunswick, OH)
|
| Correspondence Address:
|
LERNER, DAVID, LITTENBERG,;KRUMHOLZ & MENTLIK
600 SOUTH AVENUE WEST
WESTFIELD
NJ
07090
US
|
| Assignee: |
RADIOCARB GENETICS, INC.
Akron
OH
|
| Serial No.:
|
434122 |
| Series Code:
|
12
|
| Filed:
|
May 1, 2009 |
| Current U.S. Class: |
1/1; 250/395; 702/19; 707/999.003; 707/999.009; 707/E17.014; 707/E17.044; 709/203; 709/219 |
| Class at Publication: |
707/3; 250/395; 702/19; 709/219; 709/203; 707/9; 707/E17.044; 707/E17.014 |
| International Class: |
G06F 17/30 20060101 G06F017/30; G01T 1/00 20060101 G01T001/00; G06F 19/00 20060101 G06F019/00; G06F 15/16 20060101 G06F015/16 |
Claims
1. A method to analyze and report the radiocarbon content of a food
product lot, comprising the steps: a) marking a product lot with an
appropriate product lot identifier; b) taking one or more samples from
said product lot; c) marking each of said samples with an appropriate
sample identifier; d) analyzing said samples to measure the radiocarbon
content of at least one carbon-containing component of one or more
samples or mixture of samples from the same product lot; e) labeling the
product lot with the results of the radiocarbon analysis done on its
samples or otherwise providing a reporting mechanism to link the product
lot identifier to the results of the radiocarbon analysis of its samples.
2. The method of claim 1, wherein said sample radiocarbon analysis is
performed using Geiger counters, proportional counting instruments,
liquid scintillation beta counters, or accelerator mass spectrometry.
3. The method of claim 1, wherein said product lot identifier and said
sample identifier contain a computer-readable barcode.
4. The method of claim 1, wherein said product lot is from an intermediate
product used in the production of another product.
5. The method of claim 1, wherein said carbon-containing component in step
(d) comprises one or more members selected from the group consisting of
(A) protein or amino acids; (B) DNA, RNA, nucleotides, nucleosides,
purines, pyrimidines, or other nucleic acids; or (C) mixtures of (A) and
(B).
6. The method of claim 5, wherein data related to said product lot
identifiers, sample identifiers, sample radiocarbon analyses, and other
product and sample information are maintained in a computer database.
7. The method of claim 6, wherein said reporting mechanism involves using
remote computer access to query a computer database for the radiocarbon
analysis and other relevant information pertaining to a particular
product lot having a specific identifier.
8. The method of claim 7, wherein the response to said remote query
further includes recommendations or suggestions of additional low
radiocarbon products or any other nutritional products that would be
useful in either maximizing radiocarbon reduction in chromosomal
materials or in achieving any other health benefit.
9. The method of claim 5, further employing an algorithm to calculate an
overall value or grade or range indicative of the product's known or
estimated ability to either reduce the radiocarbon level of, or to reduce
genetic damage occurring in, newly formed chromosomal material in
consumers of said product, said chromosomal material comprising DNA and
histone proteins.
10. The method of claim 9, wherein said reporting mechanism uses remote
computer access, and said algorithm uses additional information about
said consumers to further refine said calculated overall value or grade
or range, said additional information comprising age, birth date, weight,
sex, and dietary information.
11. The method of claim 10, wherein said reporting mechanism provides
recommendations, suggestions or dietary menus involving additional low
radiocarbon products or any other nutritional products that would be
useful in either maximizing radiocarbon reduction in chromosomal
materials or in achieving any other therapeutic benefit.
12. The method of claim 2, in which the design or implementation of each
step is certified, approved, monitored or audited by one or more
independent auditors, public accountants, regulators, or other trusted
entity.
13. A computer-implemented method for providing personalized food
radiocarbon information for a consumer of a food product, the food
product having associated therewith product lot identification (ID)
information corresponding to a lot from which the food product
originated, the method comprising:(a) inputting to a computer system:(i)
the lot ID information from a food product which the user has acquired;
and(ii) personal consumer information comprising one or more personal
characteristics of the consumer of the food product; and(b) the computer
system calculating personalized food radiocarbon information for the
consumer based on the inputted lot ID information and personal consumer
information and based on preexisting radiocarbon information associated
with the lot ID information of the food product; and(c) delivering to the
consumer the information calculated in step (b).
14. The method of claim 13, wherein the preexisting radiocarbon
information is previously stored in computer memory or a database
accessible by the computer system.
15. The method of claim 13, wherein the computer system is located
remotely from the user and the inputting step (a) is done via a local
user computer.
16. The method of claim 15, wherein the local user computer communicates
with the computer system via the Internet.
17. The method of claim 15, wherein the personalized food radiocarbon
information is provided to the user on a display on the local user
computer.
18. The method of claim 13, further comprising calculating the
personalized food radiocarbon information based on (a) data entered about
the consumer's diet and/or eating habits and (b) specific data indicative
of the radiocarbon content of samples from the lot of the food product.
19. The method of claim 13, wherein the personal characteristics include
one or more of age, weight, sex and dietary information.
20. The method of claim 13, wherein the personalized food radiocarbon
information comprises information about the effective radiocarbon
reduction within newly formed chromosomal DNA and histones.
21. The method of claim 13, wherein the personalized food radiocarbon
information comprises information about the reduction of genetic damage
due to the radiocarbon content in the food product.
22. The method of claim 19, wherein the personalized food radiocarbon
information includes recommending additional food products to the
consumer based on one or more of the personal characteristics to achieve
a reduction in the incorporation of radiocarbon in newly formed
chromosomal DNA and histones.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001]This application claims the benefit of the filing date of U.S.
Provisional Patent Application No. 61/126,613 filed May 6, 2008, the
disclosure of which is hereby incorporated herein by reference.
BACKGROUND
[0002]The invention relates to methods for analyzing, labeling and
reporting the radiocarbon levels of food products produced for the
purpose of reducing human genetic damage, and the certification of such
methods.
[0003]Methods have been described (Matthews, U.S. Pat. No. 5,471,785;
Miekka, U.S. Pat. No. 5,956,896; Williams, including U.S. Patent
Publication 2007-0104761 and PCT Application No. PCT/US07/10775 filed May
3, 2007 (WO 2008/136793, published Nov. 13, 2008), each incorporated
herein by reference) for producing low radiocarbon plants, animals,
nutritional supplements, and related food products suitable for human
nutrition. However, no detailed methods have been provided for analyzing,
labeling, reporting, or certifying the radiocarbon levels of these
products in ways that are both useful to and trusted by consumers,
particularly when such products are intended specifically for use in
reducing chromosomal damage and consequent health risks.
SUMMARY OF THE INVENTION
[0004]In one embodiment there is provided a method to analyze and report
the radiocarbon content of a food product lot, comprising the steps: a)
marking a product lot with an appropriate product lot identifier; b)
taking one or more samples from said product lot; c) marking each of said
samples with an appropriate sample identifier; d) analyzing said samples
to measure the radiocarbon content of at least one carbon-containing
component of one or more samples or mixture of samples from the same
product lot; e) labeling the product lot with the results of the
radiocarbon analysis done on its samples or otherwise providing a
reporting mechanism to link the product lot identifier to the results of
the radiocarbon analysis of its samples.
[0005]In another embodiment, the carbon-containing component in step (d)
recited above comprises one or more members selected from the group
consisting of (A) protein or amino acids; (B) DNA, RNA, nucleotides,
nucleosides, purines, pyrimidines, or other nucleic acids; or (C)
mixtures of (A) and (B).
[0006]In still another embodiment, the method employs an algorithm to
calculate an overall value or grade or range indicative of the product's
known or estimated ability to either reduce the radiocarbon level of, or
to reduce genetic damage occurring in, newly formed chromosomal material
in consumers of said product, said chromosomal material comprising DNA
and histone proteins.
[0007]A further embodiment is directed to a computer-implemented method
for providing personalized food radiocarbon information for a consumer of
a food product, the food product having associated therewith product lot
identification (ID) information corresponding to a lot from which the
food product originated, the method comprising: (a) inputting to a
computer system: (i) the lot ID information from a food product which the
user has acquired; and (ii) personal consumer information comprising one
or more personal characteristics of the consumer of the food product; and
(b) the computer system calculating personalized food radiocarbon
information for the consumer based on the inputted lot ID information and
personal consumer information and based on preexisting radiocarbon
information associated with the lot ID information of the food product;
and (c) delivering to the consumer the information calculated in step
(b).
[0008]The invention is also directed to a computer-implemented method for
providing personalized food radiocarbon information for a consumer of a
food product, the food product having associated therewith product
identification (ID) information and lot ID information corresponding to a
lot from which the food product originated, the method comprising: (a)
inputting to a computer system: (i) the product ID information and lot ID
information from a food product which the user has acquired; and (ii)
personal consumer information comprising one or more personal
characteristics of the consumer of the food product; and (b) the computer
system calculating personalized food radiocarbon information for the
consumer based on the inputted product ID information, lot ID information
and personal consumer information and based on preexisting radiocarbon
information associated with the lot ID information of the food product.
[0009]In a specific embodiment the invention is directed to a method for
providing personalized food radiocarbon information for a consumer of a
food product, comprising: (a) providing a plurality of lots of food
products; (b) determining radiocarbon information about samples of food
products from the lots; (c) associating the radiocarbon content of the
samples from each lot with a lot ID; (d) labeling food products with the
lot ID corresponding to the lot from which the food product originates;
(e) providing a computer system for: (i) allowing user input of the lot
ID of a food product the user has acquired and personal consumer
information comprising one or more personal characteristics of the
consumer of the food product; and (ii) calculating personalized food
radiocarbon information for the consumer based on the personal consumer
information and the radiocarbon content associated with the lot ID of the
food product.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010]FIG. 1 is a flow diagram of the product and sample labeling and
analysis process used in one embodiment of the present invention.
[0011]FIG. 2 illustrates a calculation spreadsheet used to determine the
effective percentage of carbons each nucleotide and amino acid
contributes to human histones.
[0012]FIG. 3 illustrates a calculation spreadsheet used to determine the
estimated effective percentage of radiocarbon reduction provided by a low
radiocarbon food also eaten with ordinary food.
[0013]FIG. 4 illustrates a product label from an embodiment of the present
invention.
[0014]FIG. 5 is a flow diagram of a remote computer access reporting
process used in another embodiment of the present invention.
[0015]FIG. 6 illustrates operation of an embodiment of the invention
utilizing remote access by a user of a computer database comprising
stored product information.
DETAILED DESCRIPTION
[0016]Establishing and maintaining a high degree of consumer confidence is
essential when the property or characteristic which determines the
product's value is difficult to determine or cannot be directly measured
or confirmed by the average consumer. Such is the case of food products
with reduced levels of radiocarbon. Because such products appear to be
identical in terms of chemical and physical properties to ordinary food
products with natural background levels of radiocarbon, the average
consumer has no easy way of independently verifying the actual
radiocarbon level of a given product or making the best use of it.
[0017]Furthermore, if a complex product consists of numerous components,
in particular chemically distinct components, each of which may each vary
in amount and in the level of radiocarbon, it is difficult for potential
users to evaluate the suitability of that product for a particular use,
or to compare two or more such complex products to decide which will be
most effective for a particular use. Such is the case for food products
or nutritional supplements which may vary considerably in their protein,
DNA, amino acid or nucleotide content as well as in the radiocarbon level
of each of these components. Consumers need some way to know which
product will be most effective for them in reducing chromosomal damage
and thus provide the greatest potential health benefits.
[0018]As an example, consider two different nutritional supplements
containing amino acids which both claim to reduce chromosomal radiocarbon
levels. One contains 1 g each of lysine and arginine which are both 95%
reduced in radiocarbon, and the second contains 1 g each of
phenylalanine, methionine, aspartate, and tryptophan, each 98% reduced in
radiocarbon. Even though there is twice as much of the latter supplement
in terms of absolute quantity, and each component of the latter
supplement has a higher degree of radiocarbon reduction, in general the
first supplement will be much more effective in reducing the radiocarbon
level of histone proteins in human chromosomes because of the far greater
abundance of lysine and arginine residues in histones and the greater
number of carbon atoms they contribute to the chromosomes than the four
amino acids in the second product.
[0019]The present invention provides methods for analyzing, labeling,
reporting, and certifying the radiocarbon levels of low radiocarbon food
products, particularly those food products containing proteins,
hydrolyzed proteins, amino acids, nucleic acids and nucleotides or
nucleosides, including relevant components of final products as well as
components of lots used in manufacturing, so that manufacturers,
consumers or other users of these products can have high confidence in
their stated radiocarbon content. Furthermore, a method is provided to
evaluate or grade low radiocarbon products in terms of their potential
usefulness or effectiveness in achieving a targeted result, in particular
their estimated maximal or conditional effectiveness in reducing the
radiocarbon level of histones and DNA within chromosomal material (and
thus the amount of genetic damage ultimately caused by radiocarbon).
These effectiveness ratings make it considerably easier for consumers to
choose the types and amounts of low radiocarbon food products needed to
maximize possible health benefits resulting from reduction of genetic
damage from radiocarbon. Furthermore, each of the steps of this process
are well suited for standardization involving design control, auditing,
and certification by trusted authorities or outside organizations in
order establish and maintain the confidence of all consumers or users of
these low radiocarbon food products. These methods may be applied to any
food products intended for human or animal consumption, including
vegetables and fruits, grains, meats, fish, dairy products, and
nutritional supplements and additives.
[0020]For purposes of the present invention, including the description and
appended claims, the following terms shall have the indicated meanings.
[0021]Amino acids: The term "amino acid(s)", when not explicitly used to
denote a specific amino acid such as lysine or arginine, applies to not
only free amino acids, but also to salts of amino acids and to those
amino acid residues or units included within larger molecules or mixtures
of molecules, including peptides, oligopeptides, polypeptides, and
proteins, including hydrolyzed or partially hydrolyzed proteins. When
"amino acid" is prefaced with "standard" or "primary", its meaning shall
be understood to include only the twenty amino acids typically
transformed into human protein.
[0022]Comprise or comprising: Throughout the entire specification,
including the claims, the word "comprise" and variations of the word,
such as "comprising" and "comprises," as well as "have," "having,"
"includes," "include" and "including," and variations thereof, means that
the named steps, elements or materials to which it refers are essential,
but other steps, elements or materials may be added and still form a
construct with the scope of the claim or disclosure. When recited in
describing the invention and in a claim, it means that the invention and
what is claimed is considered to what follows and potentially more. These
terms, particularly when applied to claims, are inclusive or open ended
and do not exclude additional, unrecited elements or methods steps.
[0023]Consisting essentially of: In the present context, "consisting
essentially of" is meant to exclude any element or combination of
elements as well as any amount of any element or combination of elements
that would alter the basic and novel characteristics of the invention.
[0024]DNA: The term "DNA" refers to deoxyribonucleic acid, but optionally
may also be used in a general sense to include other nucleic acids such
as RNA (ribonucleic acid) and to free nucleotides or nucleosides. For
more details, especially pertaining to DNA and radiocarbon, see Williams,
U.S. Patent Publication 2007-0104761.
[0025]Foods, food supplements, and food additives: These terms are used to
describe any foods, food supplements, food additives, or any other
nutritional product or component intended for use by humans of any age as
well as for use by animals, including livestock and fish. Foods include
such products as infant formula, liquid infusions, milk and other
beverages as well as any solid or semi-solid food products. Food
supplements and additives may include any vitamins or material added to
any food or nutritional product. The general terms "food product" or
"nutritional product" may be used to describe any such food, food
supplement, food additive, or mixture thereof.
[0026]Histones: The term "histones" refers to any of the histone proteins
that may be found in chromosomal material and which closely associate
with DNA. For more details, especially pertaining to histones and
radiocarbon, see Williams, U.S. Patent Publication 2007-0104761.
[0027]Normal or Ordinary: The terms "normal" or "ordinary", when applied
to a food or a chemical substance, is used in the present disclosure and
claims to mean food or chemical substances in which the radiocarbon level
has not been deliberately or significantly reduced. Thus such materials
contain approximately 100% of the natural background level of radiocarbon
(100 pMC).
[0028]Nucleotide: The terms "nucleotide" or "nucleotides", when not
clearly used to denote a specific phosphorylated nucleoside such as dCTP
or guanosine-5'-monophosphate, are used as equivalent or alternative
expressions for any nucleotide residue within DNA or RNA, or for the
basic biochemical forms (adenosine, guanosine, cytidine, thymidine, and
uridine).
[0029]Oligonucleotide: The term "oligonucleotide" as used in the present
disclosure and claims refers to oligomers comprising two or more
nucleotide residues, typically from 2 to about 50.
[0030]Polynucleotide: The term "polynucleotide" as used in the present
disclosure and claims refers to nucleotide polymers comprising about 50
or more nucleotide residues.
[0031]Radiocarbon: The term "radiocarbon" is used in the disclosure and
claims to mean carbon-14.
[0032]Radiocarbon level or concentration: For the purposes of this
disclosure and claims, the terms radiocarbon level and radiocarbon
concentration are used interchangeably. Reference to natural, natural
abundance, background or natural background radiocarbon levels, such as
"at least about 95% below natural radiocarbon levels" or "95% radiocarbon
free", if not elsewhere defined, is based on assuming a current natural
background level of radiocarbon of about one carbon 14 atom per every 750
billion total carbon atoms. For convenience, levels of radiocarbon may
also be expressed in units of percent modern carbon (pMC), where 100% of
the current natural background radiocarbon level is equal to 100 pMC.
Thus the expression "about 95% below natural radiocarbon levels"
illustrates about a 95% reduction in radiocarbon concentration or level,
which can be expressed alternatively as "about 5 pMC." Other units for
measuring radiocarbon levels, including measures of specific
radioactivity and as described elsewhere in this disclosure, may also be
used. This invention also allows the flexibility for reporting purposes
to use any appropriate radiocarbon reference level, such as the estimated
atmospheric radiocarbon level in 1950, as the baseline or natural
background reference level, as long as the reference chosen is reasonable
and useful, and its precise definition is readily available to the end
user.
[0033]Substantially: For purposes of the present invention, unless
otherwise defined with respect to a specific property, characteristic or
variable, the term "substantially" as applied to any criteria, such as a
property, characteristic or variable, means to meet the stated criteria
in such measure such that one skilled in the art would understand that
the benefit to be achieved, or the condition or property value desired is
met.
[0034]In order to establish complete traceability of product lots, samples
chosen from the lots, and the measured radiocarbon levels of samples, it
is critical that all product lot and sample materials are adequately
marked with unique identifiers. Appropriate product lot and sample
identifiers may include numbers, strings containing any combination of
characters or numbers, GUID's (globally unique identifiers), or any other
combination of symbols or characters that can adequately identify and
distinguish lots and samples. Furthermore, human readable strings or
symbols printed on labels or reports may be accompanied by computer
readable barcodes to permit greater accuracy and process automation.
Industry standard barcode formats are generally preferred in order to
facilitate general ease of use and portability. Industry standard
barcodes which can be used to represent general alphanumeric identifiers
include but are not limited to Code 39, Code 93, Code 128-A, and Code
128-B. Industry standard barcodes which can be used to represent general
numeric-only identifiers include but are not limited to Code 11, Code 2
of 5, Interleaved 2 of 5, Plessey, MSI, and Code 128-C. These identifiers
and their barcode or symbolic representations may be printed directly on
product lot or sample packaging, or may be affixed using adhesive printed
labels or encoded within RFID (radio frequency identification) tags.
Identifiers may even consist of trace amounts of molecular tags or
encoded particles mixed into the product or samples (D. C. Pregibon et
al., Multifunctional Encoded Particles for High-Throughput Biomolecule
Analysis, Science 315, 1393-1396 (2007)).
[0035]Using a defined and documented process appropriate to the material
being measured, an adequate number of samples of sufficient size should
be randomly selected from each product lot to ensure the desired accuracy
and precision of radiocarbon measurements. These and other aspects of the
sampling process should follow generally accepted practices and
methodologies designed to minimize error and ensure reproducibility.
[0036]If it is known that the method used to grow or produce the product
guarantees a uniform radiocarbon level among all biochemical components
(particularly proteins, amino acids, nucleic acids and nucleotides), then
a single overall radiocarbon measurement can be made on each sample, and
each chemical component (such as amino acids or nucleotides) assigned
this same value. Likewise, if the method of production consistently
produces the same relative amount of radiocarbon reduction among the
various components, then a single overall radiocarbon measurement can be
made on each sample and the individual radiocarbon level of each
component can be calculated using the known relative values. Otherwise,
standard biochemical separation techniques should be applied to samples
to extract these individual biochemical components for separate
radiocarbon analyses. Although separating the samples into protein and
DNA/RNA fractions prior to radiocarbon analyses may be useful and
sufficient, further separation into individual amino acids and
nucleotides can provide further benefit if radiocarbon levels are found
to vary among these individual components. Also, if a final product lot
is formed by mixing or combining known amounts of multiple intermediate
lots each having components of known radiocarbon levels, then the
radiocarbon levels of components in the final product can be calculated
(avoiding the time, effort, and expense of additional measurement steps).
[0037]Radiocarbon measurements of sample components with precision within
about 0.5% to 1% or 2% of natural background levels can be obtained using
any of the standard analytical measurement techniques for radiocarbon
which have been applied in the field of carbon dating. If large amounts
of material are being measured and sufficient time is available,
sensitive Geiger counters or other general radiation detectors such as
proportional counters may be utilized, especially when used with shielded
chambers and with detector arrays for coincidence detection and
background elimination (Robinson, 1950; Nakhla, 1974). These may provide
inexpensive, though generally less sensitive and less rapid, measurements
of radiocarbon decay. Precision beta counters (typically liquid
scintillation detectors) may also be employed for measuring radiocarbon
decay (G. Pearson, Precise .sup.14C measurement by liquid scintillation
counting, Radiocarbon 21(1): 1-21 (1979); Verhagen, U.S. Patent
Application 20060038124). However, a preferred embodiment of this
invention uses AMS (accelerator mass spectrometry) to actually "count
atoms," which is both faster and more sensitive than measuring
radioactive decay, and is also unaffected by trace radioactive
contaminants such as tritium, potassium-40, or radium. AMS methods can be
used on microgram sized samples (J. S. Vogel et al., Accuracy and
Precision in Dating Microgram Carbon Samples, Radiocarbon 31(2):145-149
(1989)), and have even been able to measure radiocarbon levels in DNA of
selected types of human neurons (R. D. Bhardwaj et al., Neocortical
neurogenesis in humans is restricted to development, PNAS 103(33):
12564-12568 (2006)). It is thus well suited for measuring the radiocarbon
levels of components of a product that may be available in relatively
small amounts, such as individual amino acids or nucleotides. AMS is
particularly beneficial for carbon dating since it supplies accurate
measurements of all carbon isotopes, including that of carbon-13, which
is needed for compensating for heavy isotope dilution in fossil carbon.
Although it is not critical for this application to distinguish between
the stable isotopes carbon-12 and carbon-13, it can be useful for such
information to still be measured and tracked for other purposes such as
monitoring of source materials. Sample preparation of isolated components
prior to radiocarbon analyses can vary depending on the exact method
chosen, but may include combustion to carbon dioxide (see for example, A.
T. Aerts-Bijma, et al., Automatic AMS Sample Combustion and CO.sub.2
Collection, Radiocarbon 43(2a): 293-298 (2001)), or further reduction to
pure graphite or else conversion to other suitable chemical forms such as
benzene. If less precise overall measurements and longer measurement
times are acceptable, inexpensive sample preparation involving simple
dehydration and compression of the bulk sample into wafers or pellets for
proportional counting can be used.
[0038]The measured radiocarbon levels can be reported using various units.
The type of units and precision chosen can vary as long as they are
useful and understandable to the intended users. It is expected that the
most useful terminology for the general public will be in the form of a
percentage of radiocarbon reduction from the normal natural background
level, such as "95.5% radiocarbon free" or "95.5% reduction in
radiocarbon". This method would use as a reference value the approximate
natural background radiocarbon level for a particular year, preferably
standardizing on a year (such as 1950) before which atmospheric levels of
radiocarbon were significantly altered by radiocarbon from atmospheric
weapons testing. Other units of radiocarbon measurements can include
percent modern carbon (PMC), fraction modern carbon, parts per trillion
of radiocarbon, or a measure of specific radioactivity (the number of
.sup.14C disintegrations per unit of material per unit of time, such as
dpm/g, or disintegrations per minute per gram of carbon). Radiocarbon
values may also be given in ranges (ie, a radiocarbon reduction of
90-95%) or as named ranges with a predefined meaning. For example, there
may be a "moderate reduction" range corresponding to 50%-75% reduction in
radiocarbon, a "high reduction" corresponding to 75%-90%, a "very high
reduction" corresponding to 90%-95%, and an "extremely high reduction"
corresponding to 95%-100%. These levels or ranges may also be given more
user-friendly or arbitrary names such as "Good", "Better", and "Best" or
"Bronze", "Silver", and "Gold", as long as the actual numeric ranges are
clearly defined.
[0039]FIG. 1 is a flow diagram of the product and sample labeling and
analysis process used in one preferred embodiment of the present
invention. The process begins with a single food, nutritional supplement
or component product lot, which may be a final product lot intended for
direct use by consumers, or it may be an intermediate product lot
intended to be combined or mixed with other intermediate product lots
before reaching the final consumer. This food product contains at least
one carbon-containing chemical component, but more preferably
carbon-containing chemical components comprising one or more members
selected from the group consisting of (A) protein, hydrolyzed protein, or
amino acids; (B) DNA, RNA, nucleotides, nucleosides, purines,
pyrimidines, or other nucleic acids; and (C) mixtures of (A) and (B). In
step 101, a unique product lot identifier is created for a new
radiocarbon product lot. This identifier may be created using any
convenient format and preferably also including a computer readable
symbolic barcode. This identifier and barcode can be printed on labels
which are affixed to all containers or packages holding this product lot.
This product lot identifier is also entered into a computer database
along with any associated relevant information about the product lot
which it is desired to track. In step 102, a random sample of sufficient
size for radiocarbon analysis is selected from the product lot according
to a previously documented standard process. In step 103, a unique sample
identifier is created for this sample. This identifier may be created
using any convenient format and preferably also including a computer
readable symbolic barcode. This identifier and barcode can be printed on
a label which is affixed to the container or package holding the sample.
This sample identifier, along with any relevant sample description, is
entered into a computer database and linked to its parent product lot
identifier. In step 104, the sample undergoes any physical or chemical
preparation required prior to radiocarbon analysis. This analysis begins
in step 105 with standard biochemical techniques to separate the sample
into basic components which may include protein and DNA, or further into
individual nucleotides and amino acids. The absolute or relative amounts
of each of the separated components can also be quantitated. In step 106
each component is then chemically prepared using standard methods, and
its radiocarbon content analyzed, preferably by AMS (accelerator mass
spectrometry), the most sensitive analytical method currently available.
Step 107 repeats the previous isolation and analysis steps for each
additional sample component to be analyzed. Step 108 repeats steps 102
through 107 for each additional sample. A variation on the sample
selection and analysis process (steps 102 through 108) is to select
multiple samples but to combine two or more of them together prior to
analysis. It should also be noted that the process illustrated here shows
each component isolated and analyzed as separate steps, though in
practice all components can be separated in a single step and their
concentration and radiocarbon levels sequentially measured in a
continuous process. As sample radiocarbon measurements are completed, in
step 109 the data is sent to a computer system for further analysis and
database storage. This analysis may include calculating the overall
amounts and radiocarbon levels of each component in the product lot. In
step 110, the data is used to print package labels or product inserts for
use with the product lot. Alternatively, the database may be queried via
remote computer access, typically involving an Internet-based query from
a customer providing a product lot identifier and other information, and
which returns to the customer a formatted report that may contain overall
amounts of radiocarbon in each component in the product lot as well as
estimated effectiveness ratings or other information or recommendations
based on the specifics of the customer's product usage.
[0040]Once the amounts and radiocarbon levels of individual nucleotide and
amino acid residues are known for a product lot, one or more algorithms
can be used to calculate the estimated or expected effective radiocarbon
reduction within newly formed chromosomal DNA and histones. Although
various other terms or names may be used for this "effectiveness rating",
it is essentially a measurement of the reduction of genetic damage due to
radiocarbon, typically the ultimate goal for users of low radiocarbon
food products.
[0041]There are two basic types of estimated or expected effectiveness
ratings, "maximal effectiveness" and "conditional effectiveness". Maximal
effectiveness, or maximum possible effectiveness, assumes that a
sufficient amount of a low radiocarbon food product or dietary supplement
is taken to meet 100% of the body's needs for those low radiocarbon
nucleotides, amino acids, or other histone or DNA precursors included in
the product, and that none of these low radiocarbon components are
diluted by additional ingestion of foods having these same components
with natural background radiation. However, any nucleotide or amino acid
precursors absent from the low radiocarbon product will reduce the
product's maximal effectiveness, since the body's requirements for those
missing components must be met by components with natural background
level in ordinary foods. Allowances can be made for a missing
interconvertible amino acid, such as Phe or Tyr, since the body can
readily convert one to the other as needed.
[0042]For an example of calculating maximal effectiveness, if a low
radiocarbon food product contains all the required nucleotides and amino
acids, each of which are 95% depleted in radiocarbon, then the supplement
would have a 95% maximal effectiveness in reducing chromosomal
radiocarbon. However, another low radiocarbon supplement containing
nucleotides and amino acids, each of which are 95% depleted in
radiocarbon, but which was missing adenosine, thymidine, lysine, and
several other amino acids which all together contribute 40% of
chromosomal carbons, then this supplement would have a maximal
effectiveness of just 60%.times.95%, or 57%. Increasing the dosage or
amount of the second supplement cannot increase its maximum
effectiveness.
[0043]Along with every maximal effectiveness rating there should also be
an approximate minimum daily dosage or amount of the low radiocarbon
product needed to meet the body's nutritional needs for these components,
which depends on the age and or weight of the subject. If detailed
nutritional requirements for each nucleotide or amino acid are not
available, minimum dosage estimates can at least be made for amino acids
using daily overall protein requirements based on age or weight, and
optionally with the relative amount of each amino acid based on the
overall amino acid composition of the body. The minimum dosage is
dependent on the amount of the one or more components present in the
product in the smallest relative amount in comparison to the minimum
daily recommended requirement for that component or components. For
example, if 5 g of a low radiocarbon food product contains 100% of all
the nucleotides and nineteen of the amino acids required for a person of
a particular age and weight, but only 33% of the amount of the essential
amino acid leucine required, then the minimum dosage of this low
radiocarbon supplement to achieve maximal effectiveness is 15 g.
[0044]Conditional effectiveness actually applies to a specific dietary
situation involving one or more low radiocarbon foods, optionally taken
together with ordinary foods having natural background radiocarbon. It
takes into effect the composition and amounts of each different low
radiocarbon or normal food consumed, and should also ensure that overall
total protein is sufficient to meet the particular protein requirement
for the subject's age and weight.
[0045]This expected or estimated conditional effectiveness rating is a
particularly useful value to end users in that it summarizes in a single
value how beneficial the particular low radiocarbon product(s) should be
in reducing chromosomal damage in a specific person under a particular
set of overall dietary conditions. These algorithms take into account the
amounts and levels of each of the amino acid and nucleotide components in
the diet (which includes contributions both from low radiocarbon food
products as well as from ordinary foods with normal levels of
radiocarbon), together with the known or approximate amount of each amino
acid and nucleotide typically present in human chromosomal material, to
calculate the estimated effective reduction in radiocarbon for new
chromosomal material being synthesized in the body. These calculations
can use the overall human DNA GC (guanine/cytosine) base content of 41%
and AT (adenine/thymine) base content of 59% for the overall nucleotide
composition of DNA in chromatin, and data from Table 1 (taken from Table
4 in Williams, U.S. Patent Publication 2007-0104761) for the overall
amino acid contribution of carbon atoms to histone proteins in chromatin.
TABLE-US-00001
TABLE 1
Relative overall contribution of carbon to histones of human
chromatin, by amino acid, per 200 DNA base pairs
Total Each
Amino Acid
[H1 + 2 (H2A, Carbons Total
H2B, H3, % per Amino No. % Cumulative
Amino acid H4)] Residues Acid Carbons Carbons % Carbons
Lys* (K) 171 14.3% 6 1026 17.9% 17.9%
Arg (R) 110 9.2% 6 660 11.5% 29.4%
Leu* (L) 94 7.9% 6 564 9.8% 39.2%
Ala (A) 150 12.5% 3 450 7.8% 47.1%
Val* (V) 78 6.5% 5 390 6.8% 53.9%
Ile* (I) 53 4.4% 6 318 5.5% 59.4%
Thr* (T) 74 6.2% 4 296 5.2% 64.6%
Glu (E) 56 4.7% 5 280 4.9% 69.5%
Tyr** (Y) 31 2.6% 9 279 4.9% 74.3%
Pro (P) 55 4.6% 5 275 4.8% 79.1%
Ser (S) 75 6.3% 3 225 3.9% 83.0%
Gly (G) 103 8.6% 2 206 3.6% 86.6%
Gln (Q) 38 3.2% 5 190 3.3% 89.9%
Phe** (F) 19 1.6% 9 171 3.0% 92.9%
His* (H) 22 1.8% 6 132 2.3% 95.2%
Asn (N) 28 2.3% 4 112 2.0% 97.2%
Asp (D) 25 2.1% 4 100 1.7% 98.9%
Met** (M) 10 0.8% 5 50 0.9% 99.8%
Cys** (C) 4 0.3% 3 12 0.2% 100.0%
Trp* (W) 0 0.0% 11 0 0.0% 100.0%
TOTAL 1196 5736
amino carbon
acids atoms
*Essential amino acid
**Essential but interconvertible (Phe/Tyr, Met/Cys)
[0046]Should further investigation or experiments show that the overall
human histone amino acid composition significantly differs from the
composition estimated and shown in Table 1 or elsewhere in this
invention, this table listing the relative carbon contribution of each
amino acid to histones can be revised to incorporate this updated or more
accurate information, and this revised histone composition can be used to
re-estimate the optimal low radiocarbon amino acid compositions needed to
maximize reduction of radiocarbon and histones or to perform other
calculations as described in this invention. Likewise, revisions to DNA
GC and AT content, or to the relative amount of DNA and histones, can
also be handled by appropriate adjustments to the tables and calculations
used in this invention.
[0047]Algorithms used for calculating the expected effective radiocarbon
reduction or reduction of genetic damage due to radiocarbon may include
the use of one or more relative response factors (RRF's) for each
individual chemical component. These relative response factors can be
used to reflect the absorption, uptake, or other physiological issues
which might influence the net amount of each component which ultimately
becomes incorporated into chromosomal material, or that relate to the
genetic importance of each component within the chromosomal material, or
that give proper weight to those components which have the greatest
impact on birth defects, aging, cancer, or genetic diseases. For example,
relative response factors for essential amino acids may be higher than
relative response factors for non-essential amino acids since the latter
face additional competition for incorporation into histones from other
amino acid units produced within the body. Relative response factors for
nucleic acids, because of their actual incorporation within DNA, may be
higher than that of amino acids which only become incorporated into the
surrounding histones. Relative response factors for guanosine and
cytidine nucleotides may be higher than those for adenosine and thymidine
because of the tendency of gene-coding regions to be located in the
GC-rich portions of the DNA. Relative response factors for amino acids
present in larger amounts as free amino acids may be higher than for
other amino acids only present in polypeptide form and which require
proteolysis before they can be absorbed. Also, each component may have
multiple relative response factors, for example one which is
concentration independent and another which varies depending on the
amount of the component which is present. These relative response factors
may be determined based on theoretical estimates (using data such as
known GC and AT abundances in human DNA or on the relative number of
carbon atoms each type of amino acid contributes to histones), on
experimental studies performed using various combinations and amounts of
low radiocarbon nucleic acids and amino acids on microorganisms, animals,
or human volunteer subjects, or on a combination of both theory and
experiment. Such methods and the calculation of RRFs are known to a
person skilled in the art, although their application to nutritional
supplements has not previously been described.
[0048]FIG. 2 illustrates a calculation spreadsheet used to estimate the
effective percentage of carbons each nucleotide and amino acid
contributes to human chromosomal material. This data can be used in
calculating either maximal or conditional effectiveness. The data used in
this example are based on the assumptions that overall human DNA GC base
content is 41% and AT base content is 59%, that overall chromosomal
content is similar to that of a typical nucleosome having 200 DNA base
pairs associated with nine histone protein molecules--one H1 and two each
of H2A, H2B, H3, and H4 (Williams, U.S. Patent Publication 2007-0104761).
While the underlying method would remain unchanged, a revised version of
this table can be made should further research indicate that any of these
assumptions should be modified. Column A lists the individual DNA
nucleotide and histone amino acid components. Column B contains the total
number of each nucleotide or amino acid residue per nucleosome unit.
Column C contains the number of carbon atoms found in each type of
nucleotide or amino acid residue. Column D contains the product of the
values found in B and C, which equals the total number of carbon atoms
contributed by each type of nucleotide or amino acid to a nucleosome
unit. Assuming that the chromosome overall has the same relative
composition as the nucleosome, D thus contains the relative number of
carbon atoms contributed to chromosomal material by each of the
components. Column E contains a Relative Response Factor (RRF) which can
be different for each component if desired, and which is used to reflect
the relative significance of a radiocarbon decay in that material in
terms of genetic damage. In this example, for the purpose of
illustration, the nucleotides adenosine and thymidine are each given the
baseline RRF of 1.0, whereas guanosine and cytidine, which are slightly
more prevalent in coding regions of DNA and thus presumably more vital to
DNA function, are each given a slightly higher RRF of 1.1. On the other
hand, all amino acids in this example are given a lower RRF of 0.60 to
indicate that radiocarbon decay in histone proteins is estimated to be
only 60% as damaging as that to DNA adenosine and thymidine residues.
Actual RRF values may be based on the best theoretical or experimental
data available at the time, and may possibly also differ when used to
estimate different types of health risks from radiocarbon damage to
chromosomes, such as cancer, birth defects, or aging. Column F contains
the Effective (relative) Number of Carbons, and is simply the product of
Columns D and E. Finally, Column G contains the Effective Percentage of
Carbons within chromosomes for each type of DNA and histone residue, and
is simply the corresponding value in F divided by the sum of all the
values in column F, which in this example has a sum equal to 7515.4.
These values for Effective Percentage of Carbons within chromosomes for
each nucleotide and amino acid component indicate the maximum benefit
each particular component of a low radiocarbon diet will have on new
chromosomal material being built using these components. These
percentages are then used when calculating the overall expected effective
radiocarbon reduction (or reduction of genetic damage) in new chromosomal
material due to a particular low carbon diet. This is further illustrated
in the next figure.
[0049]FIG. 3 illustrates a calculation spreadsheet used to determine the
estimated effective percentage of radiocarbon reduction in new
chromosomal material (i.e., conditional effectiveness) provided by a low
radiocarbon food product which is also eaten in conjunction with ordinary
food having natural background levels of radiocarbon. Column A lists the
individual DNA nucleotide and amino acid components. Column B contains
the Effective Percentage of Carbons in the Chromosome for each component,
as calculated previously in FIG. 2 (Column G). Column C contains the
known, measured, or estimated reduction in the radiocarbon level of each
component in the low radiocarbon food. Column D contains the actual
amount (mass) of each type of component in the low radiocarbon food.
Column E similarly contains the actual amount (mass) of each type of
component in the normal food containing natural background level of
radiocarbon (and a 0% level of radiocarbon reduction). Column F is the
total amount of each component in all food eaten, and is simply the
amount of low radiocarbon food in Column D added to the amount of normal
food in Column E. Columns D, E, and F can use any appropriate measurement
of mass or weight as long as they all three use the same unit. Also, for
the purpose of this invention, only nucleotide and amino acids portions
of low radiocarbon and normal food are of interest; fats, sugars, and
other components are ignored. Column G is the amount of low radiocarbon
food as a percentage of the total food, and is simply the value in Column
D divided by the value in Column F. Column H contains the overall
effective radiocarbon reduction in the chromosome for each component. The
sum of the values in Column H is the net overall effective radiocarbon
reduction in the chromosome for all nucleotide and amino acid components
together. This is the value most useful or of most interest to the
consumer to indicate how effective a particular low radiocarbon food
product will be in reducing radiocarbon levels in new chromosomal
material when taken with the stated amount of ordinary food. Thus, in
this embodiment, the estimated overall effective radiocarbon reduction
for 7.88 g of nucleotides and amino acids in this low radiocarbon food
product taken together with 4.01 g of these components in normal food is
72.23%.
[0050]One skilled in the art can readily make numerous variations of these
embodiments, including simplified estimates of radiocarbon reduction when
all DNA or histone protein precursors have the same levels of radiocarbon
reduction and response factors, or more complicated estimates involving
several different low radiocarbon and normal foods all having components
with differing radiocarbon levels, or which involve multiple RRF's for
each component.
[0051]Most if not all radiocarbon reduction within chromosomal materials
likely occurs primarily during growth of new cells, and this varies
according to the individual's stage in life. If the subject's age, weight
and sex are available, additional estimates of chromosomal radiocarbon
reduction obtained or obtainable over an extended or arbitrary time with
a particular low radiocarbon diet can be made using growth charts
(Williams, U.S. Patent Publication 2007-0104761).
[0052]Results of radiocarbon analyses may be provided to consumers or
users of the product using labels printed on or attached to the product,
or by package inserts, or by interactive electronic reporting means
involving remote computer access, particularly via the Internet or a VPN
(virtual private network). These labels or reports may include any
relevant information pertaining to the radiocarbon analyses, including
overall radiocarbon levels and amounts of material, radiocarbon levels
and amounts of individual components (nucleic acids, nucleotides,
protein, amino acids, etc.), recommended serving sizes or dosages,
recommendations of additional complementary low radiocarbon products or
other general nutritional products, and estimates of expected reduction
of radiocarbon in chromosomal materials or of expected reduction in
chromosomal damage events. These labels may further include mechanisms to
minimize fraud and counterfeiting. Such anti-fraud mechanisms may include
allowing end users online access to a central low radiocarbon
certification authority to use a unique barcode on the package to look up
details related to that particular package or product lot, including time
and date packaged, location(s) where it was sold, and other manufacturer
or package details. Labels or associated packaging can also employ
difficult-to-forge seals, complex printing, holograms, RFID tags, or
similar fraud prevention devices.
[0053]FIG. 4 illustrates a sample product label of one preferred
embodiment. Item 401 is the computer readable product lot identifier
barcode, in this instance using Code 128-B format and including
human-readable text immediately below. Item 402 is the product name. Item
403 is the product lot number, and item 404 is the product identifier. In
this example the complete product lot identifier encoded in the barcode
includes both the product id and the lot number. Item 405 is a table
listing all the relevant chemical components within this product that
have a direct impact on chromosomal material, their amounts, and their
radiocarbon levels. Item 406 provides values for the estimated overall
effectiveness of this product in reducing chromosomal radiocarbon for two
particular product usage situations. Item 407 directs the user to an
Internet location where additional useful product information may be
obtained.
[0054]Interactive electronic reporting of results using the Internet, a
VPN, or other electronic networks may also be done in a wide variety of
mechanisms. However, one element common to all these mechanisms is that
the user must provide a product lot identifier. Additional optional
information which may be queried can include customer specific details
such as weight, age or birth date, sex, type of diet, dietary
preferences, or relevant health issues. These customer specific details
should preferably remain anonymous in order to protect the privacy rights
of the customer, but for convenience may optionally be persisted on
either the client's machine or the Internet server using standard
mechanisms such as customer profiles or cookies.
[0055]FIG. 5 is a flow diagram of one preferred embodiment which includes
detailed reporting of product information over the Internet. In step 501
the user or customer connects to the appropriate web site URL (Uniform
Resource Locator), and the web server responds by providing the user with
a query form containing one or more data input fields. In step 502 the
user enters in the unique identifier or barcode for the product lot of
the particular low radiocarbon product they are interested in. In step
503 the user may optionally enter additional information about the
intended consumer, such as birth date or age, weight, sex, the amount of
the low radiocarbon product being consumed, types and amounts of other
normal food being eaten, dietary preferences, or similar personal
information. This personal information is preferably anonymous to protect
user privacy, but for convenience may be stored or persisted on either
the server or client PC using standard means which may include user
profiles or cookies. After entering all requested data, in step 504 the
user submits this data back to the server. In step 505 the server
performs any necessary database lookups of product information or user
profile settings, and uses this information to calculate amounts and
radiocarbon levels of various product components such as amino acids and
nucleotides, as well as the estimated effectiveness of the product in
reducing radiocarbon incorporation into the chromosomal material of the
consumer based on the data previously provided by the user. In step 506
the server formats and returns the results in a user-friendly report
format which may also include additional explanatory material or
hyperlinks to additional information or alternative reports. In step 507
the user is offered an opportunity to create a report printout (508). In
step 509 the user is offered an opportunity to create a dietary menu
(510) listing suggested types and amounts of various low radiocarbon food
items which may be appropriate for the consumer in achieving a desired
level of chromosomal radiocarbon reduction.
[0056]Internet or other interactive reporting mechanisms may facilitate
"what if" scenarios where the user can enter the type and amount of any
number of different normal and low radiocarbon food products consumed
over various periods of time to estimate the overall effectiveness in
reducing radiocarbon incorporation into chromosomal material or in
reducing genetic damage events.
[0057]Interactive reporting mechanisms may also provide recommendations of
other low radiocarbon or even normal radiocarbon food products or
supplements which may be useful in maximizing radiocarbon reduction of
chromosomal material or in providing any other health benefit. For
example, a consumer may enter personal information such as age and weight
together with the types and amounts of a number of low radiocarbon and
normal food products intended to be eaten over a given period of time. If
the combination of food products shows that the normal food contains
considerable lysine, it may recommend additional supplementation with low
radiocarbon lysine, within safe limits. Also, if the foods listed by the
consumer are low in a particular vitamin or mineral, it may recommend the
appropriate vitamin or mineral supplements, even though these have no
direct impact on radiocarbon reduction of chromosomal material.
[0058]FIG. 6 illustrates operation of an embodiment of the invention
utilizing remote access by a user of a computer database comprising
stored product information, for example, as described and discussed
above. For example, including in FIG. 6 is a computer system comprising a
server, database and disk storage medium, on which data and information
about samples and products can be stored. Such information can also be
included on products, including intermediate products used to make final
products for sale to the consumer; information can include identification
information in computer readable form. A user, including multiple users,
can access the computer system using alternative devices, including
tele
phones, cell
phones, personal digital assistants, as well as laptop
and desktop computers. Suitable access can be acquired via telephone,
cable, fiber and other systems known in the art, including in particular,
the world wide web or internet.
[0059]Additional relevant standard product analyses and certification
steps not related to radiocarbon may also be done in conjunction with
this method. For example, a food product may be certified both in terms
of overall radiocarbon content, protein radiocarbon content and nucleic
acid radiocarbon content, and may also have a standard "Nutritional
Facts" analysis of fat, carbohydrate, protein, vitamins, and minerals
which is independent of radiocarbon. This additional information may be
provided on a separate label or may be combined on a single label
together with radiocarbon-related information.
[0060]Furthermore, the processes of labeling and tracking low radiocarbon
product lots and samples as described here can be further integrated in a
more comprehensive tracking system, such as ones that monitor
agricultural or livestock products from planting or birth and on through
harvesting or slaughter, processing, and packaging (Montanari et al.,
U.S. Pat. No. 5,478,990; Beck et al., U.S. Pat. No. 7,085,777).
[0061]Industry standards and quality systems regulations such as ISO 9000
(from the International Organization for Standardization, www.iso.org),
GMP (Good Manufacturing Practices,
http://www.fda.gov/cdrh/devadvice/32.html), or from GAMP (Good Automated
Manufacturing Practice, www.ispe.org/gamp) may be adopted in whole or in
part in creating and implementing a particular certified process
according to this invention. Particular aspects of this invention which
can be implemented in coordination with trusted and qualified outside
organizations include:
[0062]Design or approval of the processes used in product and sample
handling, labeling, and tracking.
[0063]Design or approval of the processes related to the chemical
processing or separation techniques employed.
[0064]Design or approval of the processes related to the calibration,
maintenance and operation of analytical instruments.
[0065]Design or approval of the computer data system, including its
implementation, reliability, accuracy, performance, scalability, backup
and security, with particular attention to means of preventing tampering
or other deliberate or accidental altering or loss of data.
[0066]Design or approval of the reporting system or labeling used
(accurate as well as clear and understandable to end users).
[0067]Design or approval of training materials and training programs for
personnel performing any of these processes.
[0068]Design or approval of troubleshooting, error correction and
avoidance, and risk management processes.
[0069]Design or approval of documentation control and change control
processes.
[0070]Ongoing random sampling, monitoring or auditing by outside agencies
or organizations to ensure continued compliance.
[0071]A preferred embodiment of this invention involves using AMS for
measuring the radiocarbon levels of individual amino acid and nucleotide
components in samples taken from a low radiocarbon food product according
to the process shown in FIG. 1, then applying an algorithm for estimating
the effectiveness of a low radiocarbon product as illustrated in FIG. 2
and FIG. 3, then applying a product label similar to that illustrated in
FIG. 4 to the product package, furthermore employing a qualified outside
organization to certify the design, documentation and implementation of
each of the essential processes or steps involved.
[0072]Additional modifications within the spirit of the invention will be
apparent to those skilled in the art. For example, low radiocarbon
products containing essentially only protein may receive a radiocarbon
reduction effectiveness rating which only pertains to the estimated
amount of radiocarbon reduction within histones and which ignores any
impact on DNA. As another example, the graphic format or layout or fonts,
the type of barcode or barcodes, and the selection and ordering of
individual components which appear on the labels or reports may be
altered as necessary to satisfy business or regulatory requirements. A
further embodiment includes product information, marketing, advertising,
or direct product ordering links on an Internet reporting form.
[0073]Another embodiment is directed to a computer-implemented method for
providing personalized food radiocarbon information for a consumer of a
food product, the food product having associated therewith product
identification (ID) information and lot ID information corresponding to a
lot from which the food product originated, the method comprising: (a)
inputting to a computer system: (i) the product ID information and lot ID
information from a food product which the user has acquired; and (ii)
personal consumer information comprising one or more personal
characteristics of the consumer of the food product; and (b) the computer
system calculating personalized food radiocarbon information for the
consumer based on the inputted product ID information, lot ID information
and personal consumer information and based on preexisting radiocarbon
information associated with the lot ID information of the food product.
[0074]A further embodiment is directed to a computer-readable medium for
storing instructions for causing a computer to perform a method for
providing personalized food radiocarbon information for a consumer of a
food product, the food product having associated therewith product lot ID
information corresponding to a lot from which the food product
originated, the instructions causing the computer to: (a) provide an
interface to allow user input of: (i) the product lot ID information of a
food product which the user has acquired; and (ii) personal consumer
information comprising one or more personal characteristics of the
consumer of the food product; and (b) calculate personalized food
radiocarbon information for the consumer based on the inputted lot ID
information and personal consumer information and based on preexisting
radiocarbon information associated with the lot ID information of the
food product.
[0075]In another embodiment is directed to a method for providing
personalized food radiocarbon information for a consumer of a food
product, comprising: (a) providing a plurality of lots of food products;
(b) determining radiocarbon information about samples of food products
from the lots; (c) associating the radiocarbon content of the samples
from each lot with a lot ID; (d) labeling food products with the lot ID
corresponding to the lot from which the food product originates; (e)
providing a computer system for: (i) allowing user input of the lot ID of
a food product the user has acquired and personal consumer information
comprising one or more personal characteristics of the consumer of the
food product; and (ii) calculating personalized food radiocarbon
information for the consumer based on the personal consumer information
and the radiocarbon content associated with the lot ID of the food
product.
[0076]Any range of numbers recited in the specification hereinabove or in
the paragraphs and claims hereinafter, referring to various aspects of
the invention, such as that representing a particular set of properties,
units of measure, conditions, physical states or percentages, is intended
to literally incorporate expressly herein by reference or otherwise, any
number falling within such range, including any subset of numbers or
ranges subsumed within any range so recited. Furthermore, the term
"about" when used as a modifier for, or in conjunction with, a variable,
characteristic or condition is intended to convey that the numbers,
ranges, characteristics and conditions disclosed herein are flexible and
that practice of the present invention by those skilled in the art using
temperatures, concentrations, amounts, contents, carbon numbers and
properties that are outside of the range or different from a single
value, will achieve the desired result, methods, particularly
computer-implemented methods, for analyzing, labeling, reporting, and
certifying the radiocarbon abundance levels of low radiocarbon food
products, including relevant chemical components of final products as
well as components of lots used in manufacturing, so that manufacturers,
consumers or other users of these products can have high confidence in
their stated radiocarbon content and a better understanding of their
potential effectiveness in reducing genetic damage.
[0077]All documents described herein are incorporated by reference herein,
including any priority documents and/or analytical procedures. The
principles, preferred embodiments, and modes of operation of the present
invention have been described in the foregoing specification. Although
the invention herein has been described with reference to particular
embodiments, it is to be understood that these embodiments are merely
illustrative of the principles and applications of the present invention.
It is therefore to be understood that numerous modifications may be made
to the illustrative embodiments and that other arrangements may be
devised without departing from the spirit and scope of the present
invention as defined by the appended claims.
[0078]References Cited
[0079]U.S. Patent Documents:
TABLE-US-00002
Document No. Published Inventor
U.S. Pat. No. 5,471,785 December 1995 Matthews
U.S. Pat. No. 5,478,990 December 1995 Montanari et al.
U.S. Pat. No. 5,956,896 September 1999 Miekka et al.
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